BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTEP COVID-19 ANTIGEN PEN HOME TEST

    MDR report key: 19828038 · Received July 24, 2024

    Report

    Report Number
    MW5157578
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 21, 2024
    Manufacturer
    AZURE BIOTECH INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN USING FASTEP COVID-19 ANTIGEN PEN HOME TEST (ACCORDING TO THE DIRECTIONS (AND HAVING USED ONE OF THE SAME TESTS SUCCESSFULLY IN THE PAST) THE SWAB BECAME LODGED IN MY RIGHT NOSTRIL. I COULD NOT REMOVE IT WITH MY FINGERTIPS. I FINALLY DISLODGED IT BY BLOWING MY NOSE VIGOROUSLY. I BELIEVE THIS COULD BE A PROBLEM IF A PARENT ADMINISTERED THE TEST TO A CHILD. TEST INFO: REF:COV-S35002H2, LOT: I2312271, MFG 2023-12-22, EXP: 2025-09-21.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484838 FASTEP COVID-19 ANTIGEN PEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP AZURE BIOTECH INC. COV-S35002H2 I2312271

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other